Gender-based Differences in the Outcome of Treatment With Aldosterone Antagonists in Patients With Heart Failure (GBDAL-HF)

A

Alexandria University

Status

Completed

Conditions

Heart Failure NYHA Class II
Heart Failure NYHA Class IV
Heart Failure NYHA Class III
Heart Failure With Reduced Ejection Fraction
Heart Failure

Treatments

Drug: Potassium sparing diuretic

Study type

Observational

Funder types

Other

Identifiers

NCT06233695
GBDAL-HF Trial

Details and patient eligibility

About

Heart failure (HF) is a major healthcare problem. In patients with Heart Failure with Reduced Ejection Fraction (HFrEF), aldosterone antagonists reduce mortality and hospitalization rate. Gender-related differences have been described in the regulation of renin angiotensin aldosterone system (RAAS), which is at the core of the pathophysiology of HF. Regarding gender-related differences in the use of MRAs, less is known about the effects of androgens on RAAS. In this single-center prospective cohort, a total of 100 adult (≥ 18 years) ambulatory patients of both sexes with the diagnosis of HF with HFrEF (LVEF≤ 40%) and NYHA class II-IV under optimized medical therapy started an aldosterone antagonist are enrolled and followed-up for 6 months. Patients are categorized according to their apparent sexual gender into two groups: the male group and the female group.

Enrollment

100 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • The diagnosis of heart failure with reduced ejection fraction HFrEF (LVEF≤ 40%) and New York Heart Association (NYHA) class II-IV under optimized medical therapy who are presented to the outpatient clinic and started an aldosterone antagonist at the time of enrollment.

Exclusion criteria

  • Pregnancy or breast-feeding.
  • Serum creatinine > 2.5 mg/dL (221 μmol/L) in males and > 2 mg/dL (177 μmol/L) in women (or estimated glomerular filtration rate eGFR ≤ 30 mL/minute/1.73 m2).
  • Hyperkalemia (serum potassium level > 5 mEq/L).
  • Renal transplant.
  • Concomitant administration of strong CYP3A inhibitors.
  • Concomitant administration of potassium supplements or potassium-sparing diuretics.
  • Disorders of adrenal glands (Addison disease).
  • Patients who used mineralocorticoid receptor antagonists in the last 2 weeks before enrollment.
  • Patients with a history of mineralocorticoid receptor antagonists allergy or intolerance.

Trial design

100 participants in 2 patient groups

The Female Group
Description:
Patients with an apparent gender of female.
Treatment:
Drug: Potassium sparing diuretic
The Male Group
Description:
Patients with an apparent gender of male.
Treatment:
Drug: Potassium sparing diuretic

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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